'Pa­tients are not a com­pa­ny's re­source': FDA can­cer czar Richard Paz­dur has a bone to pick with the top R&D ex­ecs in can­cer

If there’s one law in on­col­o­gy R&D, it’s that you don’t cross FDA can­cer czar Richard Paz­dur. Paz­dur is fa­mous for cut­ting com­pa­nies to shreds dur­ing pan­el re­views if they come to the agency with ques­tion­able da­ta af­ter stray­ing from the path he set for them. 

A blunt speak­er, Paz­dur tends to de­liv­er on what he says. When he stood up at AS­CO sev­er­al years ago to say that the break­through ther­a­py des­ig­na­tion was im­por­tant and that the agency would start hus­tling along ac­cel­er­at­ed re­views for can­cer pa­tients, he de­liv­ered on every word — spurring a rev­o­lu­tion in the way can­cer drug tri­als are de­signed and ex­e­cut­ed and in­flu­enc­ing the en­tire field of re­search and de­vel­op­ment.

And now he’s clear­ly un­hap­py with the way the on­col­o­gy R&D world has un­leashed thou­sands of stud­ies in­volv­ing a rapid­ly pro­lif­er­at­ing set of PD-1/L1 check­point ther­a­pies that have cre­at­ed a whole new megablock­buster fran­chise for in­dus­try play­ers to tack­le.

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